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China Takayasu Arteritis Registry (CTA Registry)

NCT ID: NCT02964364

Last Updated: 2016-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2026-07-31

Brief Summary

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Takayasu arteritis (TA) is a chronic large-vessel vasculitis that mainly affects the aorta and its major branches. The epidemiology and pathophysiology of TA is still unclear in China, although many studies have been done. Our previous study supporting by National Natural Science Foundation of China indicated the cytokines such as hs-CRP, NT-proBNP and tumor necrosis factor-alpha (TNF-α) can be used to monitor TA activity, and HLA gene alleles were associated with TA in Chinese han population. Further investigations with larger samples are needed to fully understand the a pathophysiology of TA. The purpose of this study is to build a Chinese national registry system for TA to obtain real-world information, such as current status of characteristics, diagnosis, disease activity, the severity of disease, treatment and outcomes of Chinese TA patients. To analysis and development of effective disease monitoring and treatment strategies.

Detailed Description

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Takayasu arteritis (TA) is a chronic vasculitis that causes inflammation of the aorta and its main branches and is characterized by adventitial thickening and cellular infiltration of the tunica media, with local destruction of vascular smooth muscle cells and elastin. The disease is very rare but most commonly occurs in China. In the last decade, the results of our study indicated that HLA-DPB1, HLA-DQA1, HLA-DQB1 and HLA-DRB1 gene alleles were associated with TA in Chinese Han population. And the clinical features of patients with TA were analyzed. The cytokines such as hs-CRP, NT-proBNP and tumor necrosis factor-alpha (TNF-α) can be used to monitor TA activity. But there are still many unknown fields in TA, such as the epidemiology and pathophysiology. This study is to build a Chinese national registry system for TA to obtain real-world information, such as current status of characteristics, diagnosis, disease activity, the severity of disease, treatment and outcomes of Chinese TA patients. To analysis and development of effective treatment strategies.

Conditions

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TAKAYASU ARTERITIS

Keywords

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TAKAYASU ARTERITIS

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Age at disease onset \< 40 years. (Development of symptoms or findings related to Takayasu arteritis at age \<40 years)
* Claudication of extremities. (Development and worsening of fatigue and discomfort in muscles of 1 or more extremity while in use, especially the upper extremities)
* Decreased brachial artery pulse. (Decreased pulsation of 1 or both brachial arteries)
* BP difference \>10 mm Hg. (Difference of \>10 mm Hg in systolic blood pressure between arms)
* Bruit audible on auscultation over 1 or both subclavian arteries or abdominal aorta.
* Arteriogram abnormality. (Arteriographic narrowing or occlusion of the entire aorta, its primary branches, or large arteries in the proximal upper or lower extremities, not due to arteriosclerosis, fibromuscular dysplasia, or similar causes; changes usually focal or segmental)

Exclusion Criteria

* Vessel lesions that could be entirely due to atherosclerosis.
* Giant cell arteritis or other infectious forms of large vessel vasculitis.
Minimum Eligible Age

5 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aimin Dang

OTHER

Sponsor Role lead

Responsible Party

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Aimin Dang

Fuwai Hospital, Chinese Academy of Medical Sciences

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Aimin Dang, MD,PhD

Role: CONTACT

Phone: +8610-88322131

Email: [email protected]

Naqiang lv, MD,PhD

Role: CONTACT

Phone: +8610-88322131

Email: [email protected]

Facility Contacts

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Naqiang Lv, Doctor

Role: primary

Other Identifiers

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NSFC 30770859

Identifier Type: -

Identifier Source: org_study_id